Effect of Digestive Enzymes as Add on Therapy on Patients With Functional Dyspepsia.
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRakibul Mostafa
About this trial
The goal of this clinical trial is to assess the effect of digestive enzymes in improving dyspeptic symptoms in patients with functional dyspepsia. It will also assess about the safety of drug by recording the patient reported adverse events. The main questions it aims to answer are:
Does drug digestive enzymes has any effect on patients with functional dyspepsia? What medical problems do participants have when taking drug digestive enzymes? Researcher will compare drug digestive enzymes to a control group taking standard first line treatment only.
Participants will:
Take drug digestive enzymes 325 milligrams 3 times daily, every day for 4 weeks along with standard first line treatment. A second group will be taken as control arm who will be kept on standard first line treatment only for 4 weeks. They will visit the hospital 2 weekly, and their symptoms will be assessed by a 5-point Likert Scale at baseline, week 2 and 4. Additionally, patient reported adverse events will be documented.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 years or more
Patients with FD diagnosed according to ROME IV criteria
Disqualifiers
Structural lesion in endoscopy and positive H. pylori status
History of malignancy, liver and biliary tract disease, diabetes mellitus, chronic kidney disease, thyroid disorders
Psychiatric disorders
Previous history gastrointestinal surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Digestive enzyme 325mg
DrugDigestive enzyme will be given to group A patient
PPI 20 mg + Domperidone 10 mg
DrugGroup B patient will get first line treatment only for 1 month
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Group-AExperimental treatment 1 intervention
Group B: Group-BActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in dyspeptic symptom
The change of four dyspeptic symptoms (Postprandial fullness, Early Satiety, Epigastric pain, Epigastric burning) will be assessed by a 5-point Likert Scale. The four main symptoms of dyspepsia, each will be graded as 1 (No problem), 2 (Mild problem, can be ignored when not thinking about it), 3 (Moderate problem, cannot be ignored but does not influence daily activities), 4 (Severe Problem, influences concentration on daily activities), 5 (Very severe problem, markedly influences daily activities or requires rest or both). The total minimum value is 4 and maximum value is 20. Higher score means worse outcome.
Time frame
At baseline and then at week 2 and 4 after randomizationSecondary outcomes
1
See the effect of digestive enzymes compared to first line treatment only
Effect of digestive enzymes on four dyspeptic symptoms (Postprandial fullness, Early Satiety, Epigastric pain, Epigastric burning) will be assessed and compared to first line treatment only by a 5-point Likert Scale. The four main symptoms of dyspepsia, each will be graded as 1 (No problem), 2 (Mild problem, can be ignored when not thinking about it), 3 (Moderate problem, cannot be ignored but does not influence daily activities), 4 (Severe Problem, influences concentration on daily activities), 5 (Very severe problem, markedly influences daily activities or requires rest or both). The total minimum value is 4 and maximum value is 20. Higher score means worse outcome.
Time frame
At baseline and then at week 2 and 4 after randomization2
Adverse events
Patient reported adverse events will be documented
Time frame
Through study completion, an average of 1 year3
Persistence of symptom improvement or recurrence of dyspeptic symptoms
Persistence of symptom improvement or recurrence of four dyspeptic symptoms (Postprandial fullness, Early Satiety, Epigastric pain, Epigastric burning) after discontinuation of digestive enzymes will be assessed and compared by a 5-point Likert Scale. The four main symptoms of dyspepsia, each will be graded as 1 (No problem), 2 (Mild problem, can be ignored when not thinking about it), 3 (Moderate problem, cannot be ignored but does not influence daily activities), 4 (Severe Problem, influences concentration on daily activities), 5 (Very severe problem, markedly influences daily activities or requires rest or both). The total minimum value is 4 and maximum value is 20. Higher score means worse outcome.
Time frame
At week 8 after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rakibul Mostafa
Lead sponsor
Dhaka Medical College
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: